中文摘要
伊德卡布他仑赛(ide-cel)在复发/难治性多发性骨髓瘤(RRMM)患者中已显示出优异疗效和持久缓解,但其用于髓外病变(EMD)患者的结局尚未充分明确。
我们纳入了 2021 年 5 月至 2023 年 4 月期间在美国 11 家学术机构接受 ide-cel 治疗的 RRMM 患者。骨骼之外、与骨不连续的内脏或软组织病灶定义为 EMD。自 ide-cel 输注日起进行事件时间分析。351 例患者中,84 例(24%)输注前存在 EMD。输注后中位随访 18.2 个月(95% CI:17–19.3)。第 90 天 EMD 组和非 EMD 组总缓解率(ORR)分别为 52% 和 82%(p<0.001)。EMD 组中位无进展生存期(PFS)为 5.3 个月(95% CI:4.1–6.9),非 EMD 组为 11.1 个月(95% CI:9.2–12.6;p<0.0001)。多变量分析显示,EMD 是 PFS 较差的独立预测因素[风险比 1.5(1.1–2.2),p=0.02]。EMD 组和非 EMD 组中位总生存期分别为 14.8 个月[95% CI:9 个月至未达到(NR)]和 26.9 个月(26.3 个月至 NR;p=0.006)。在接受 ide-cel 治疗的患者中,髓外病变是第 90 天 ORR 较低和 PFS 较差的独立预测因素。
展开英文摘要原文
Idecabtagene vicleucel (Ide-cel) has demonstrated excellent efficacy and durable responses in patients with relapsed/refractory multiple myeloma (RRMM).
However, the outcomes with ide-cel in patients with extramedullary disease (EMD) remain incompletely characterized.
We included patients with RRMM treated with ide-cel between May 2021 and April 2023 across 11 US academic institutions. Visceral or soft tissue lesions non-contiguous from bone was classified as EMD. Time-to-event analyses were performed from date of ide-cel infusion. Among 351 patients, 84 (24%) had EMD prior to infusion. The median follow-up from ide-cel infusion was 18. 2 months (95% CI: 17-19. 3). The day 90 overall response rates (ORR) were 52% vs. 82% for the EMD and non-EMD cohorts, respectively (p < 0. 001). The median progression-free survival (PFS) was 5.
3 months (95% CI: 4. 1-6. 9) for the EMD cohort vs. 11. 1 months (95% CI: 9. 2-12. 6; p < 0. 0001) for the non-EMD cohort. In a multivariable analysis, EMD was an independent predictor of inferior PFS [hazard ratio 1. 5 (1. 1-2. 2), p = 0. 02]. The median overall survival was 14. 8 months [95% CI: 9-Not reached (NR)] vs. 26. 9 months (26. 3 vs. NR, p = 0. 006) for the EMD and non-EMD cohorts, respectively. Extramedullary disease represents an independent predictor of inferior day 90 ORR and PFS among patients treated with ide-cel.
论文信息
- 作者
- Zanwar S、Sidana S、Shune L、Puglianini OC、Pasvolsky O、Gonzalez R、Dima D、Afrough A
- 第一作者单位
- Division of Hematology, Department of Medicine, Mayo Clinic, 200 1st St SW, Rochester, MN, 55905, USA.United States
- 通讯作者单位
- Blood and Marrow Transplant and Cellular Immunotherapy, H. Lee Moffitt Cancer Center, Tampa, FL, USA. Doris.Hansen@moffitt.org.United States
- 文献类型
- 读者来信 · 多中心研究
- 期刊
- Journal of hematology & oncology2024 Jun 6